Kelapril 5 mg, Film-coated Tablets for Dogs and Cats

Country: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Benazepril Hydrochloride

Fáanlegur frá:

Kela N.V.

ATC númer:

QC09AA07

INN (Alþjóðlegt nafn):

Benazepril Hydrochloride

Lyfjaform:

Film-coated tablet

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Cats, Dogs

Lækningarsvæði:

Cardio Vascular ACE inhibitor

Leyfisstaða:

Authorized

Leyfisdagur:

2013-02-11

Vara einkenni

Revised: December 2017
AN: 00122/2017
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
KELAPRIL 5 mg, film-coated tablets for dogs and cats (BE, CZ, DE, HU,
LU, NL, PL,
PT, SK, UK)
KELAPRIL 5, film-coated tablets for dogs and cats (FR)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
ACTIVE SUBSTANCE:
Benazepril Hydrochloride...............5 mg
(equivalent to Benazepril 4.6 mg)
EXCIPIENTS:
Titanium dioxide (E171) 0.52 mg
Iron oxide yellow (E172) 0.06 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Light yellow, oval divisible tablets scored on both sides.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dogs:
Treatment of congestive heart failure.
Cats:
Reduction of proteinuria associated with chronic kidney disease.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
any of the
excipients.
Do not use in cases of hypotension, hypovolaemia, hyponatraemia or
acute renal
failure.
Do not use in cases of cardiac output failure due to aortic or
pulmonary stenosis.
Do not use in pregnancy or lactation (see section 4.7).
Page 1 of 7
Revised: December 2017
AN: 00122/2017
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i) Special precautions for use in animals
No evidence of renal toxicity of the veterinary medicinal product has
been observed
(in dogs or cats) during clinical trials, however, as is routine in
cases of chronic
kidney disease, it is recommended to monitor plasma creatinine, urea
and
erythrocyte counts during therapy.
The efficacy and safety of the product has not been established in
dogs and cats
below 2.5 kg body weight.
ii) Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
Wash hands after use.
To avoid accidental ingestion, particularly by a child, unused
part-tablets should be
returned to the open blister space and inserted b